Phase 1 clinical trial

Treatment with equecabtagene autoleucel, known for short as eque-cel — Iaso Biotherapeutics‘ CAR T-cell therapy candidate for people with progressive forms of multiple sclerosis (MS) — was well tolerated and led to an easing of disability for five patients taking part in a Phase 1 clinical trial. The…

Lucid-MS, an oral small-molecule being developed by Quantum Biopharma for treating multiple sclerosis (MS), was found to be safe and well tolerated in healthy adult volunteers when given daily in a clinical study, according to the company’s latest CSR, or clinical study report. An earlier Phase 1…

A Phase 1 clinical trial that is investigating a new vaccine against the Epstein-Barr virus (EBV), a well-established risk factor for developing multiple sclerosis (MS), in healthy volunteers has dosed its first participant. The vaccine, called MDX2201, is being developed by Modex Therapeutics, an Opko Health company,…

IMP761, an experimental immunotherapy Immutep is developing for multiple sclerosis (MS) and other autoimmune conditions, has shown a promising safety profile in an ongoing Phase 1 clinical trial  in healthy volunteers, with no treatment-related side effects reported to date, the company said. The first-in-human Phase 1 trial…

The U.S. Food and Drug Administration (FDA) has given the green light to Immpact Bio to conduct a Phase 1 clinical trial to test IMPT-514, its experimental cell therapy, in people with multiple sclerosis (MS). With the investigational new drug (IND) clearance by the FDA, Immpact Bio now…

Indapta Therapeutics will launch a Phase 1 clinical trial in the U.S. in the second half of 2024 to explore its cell-based therapy IDP-023 in people with progressive forms of multiple sclerosis (MS). The announcement follows the U.S. Food and Drug Administration’s (FDA) clearance of the company’s investigational…

Immutep has been cleared to start a Phase 1 clinical trial in the Netherlands to test IMP761, its experimental antibody therapy for autoimmune diseases such as multiple sclerosis (MS), in healthy volunteers. The first-in-human Phase 1 clinical trial seeks to assess the safety and pharmacological properties of IMP761.

Abata Therapeutics is expected to launch a Phase 1 clinical trial by the end of the year to test ABA-101, its experimental therapy for progressive multiple sclerosis (MS), after getting a green light from the U.S. Food and Drug Administration (FDA). The FDA approved Abata’s investigational new drug…

The U.S Food and Drug Administration (FDA) authorized an investigational new drug application from Synaptogenix, clearing the company to launch a clinical trial to test whether its lead candidate bryostatin-1 can prevent cognitive decline in people with multiple sclerosis (MS). The open-label, Phase 1 clinical trial (NCT06190912),…

FSD Pharma has entered an agreement to launch a Phase 1 clinical trial that will test multiple ascending doses of Lucid-21-302 — an oral treatment candidate commonly known as Lucid-MS, for all types of multiple sclerosis (MS) — in healthy volunteers. The company’s subsidiary Huge Biopharma Australia established…

Monte Rosa Therapeutics is planning to initiate a Phase 1 clinical trial to test MRT-6160, its investigational therapy for multiple sclerosis (MS) and other autoimmune diseases, by mid-2024. The trial will follow the submission of an investigational new drug (IND) application, a formal request to U.S. regulatory authorities…

A Phase 1 clinical trial evaluating LPX-TI641, Lapix Therapeutics‘ experimental therapy for multiple sclerosis (MS) and other autoimmune diseases, has dosed its first participants. The first-in-human trial (NCT05853835) of healthy adult volunteers follows the recent clearance of an investigational new drug application by the U.S. Food…

FSD Pharma’s Lucid-21-302 — an oral treatment candidate known as Lucid-MS, for all types of multiple sclerosis (MS) — was found safe and well tolerated across multiple doses in healthy volunteers, according to interim data from a Phase 1 clinical trial. The newly released data are from the…

Anokion has finished enrolling patients in the second part of its Phase 1 clinical trial investigating ANK-700 for relapsing-remitting multiple sclerosis (RRMS). Safety data so far from the MoveS-it trial (NCT04602390) has shown the treatment is safe and well tolerated and biomarker analyses suggest it can induce…

Imcyse has completed patient enrollment and initial dosing in a Phase 1 clinical trial evaluating IMCY-0141, its next-generation immunotherapy, in people with relapsing-remitting multiple sclerosis. The study, the first portion of a Phase 1/2 trial called IMCY-MS-001 (NCT05417269), is an open-label trial evaluating three doses of IMCY-0141…

Nura Bio has launched a Phase 1 clinical trial evaluating NB-4746, its investigational treatment for multiple sclerosis (MS) and several other neurological conditions, in healthy volunteers. The trial’s participants will be randomly assigned to receive single and multiple doses of NB-4746 or a placebo. The goal is to…

Synaptogenix is teaming up with Cleveland Clinic for a Phase 1 clinical trial involving people with multiple sclerosis (MS) that will test the company’s lead candidate, bryostatin-1 — a therapy designed to prevent cognitive deficits in MS patients. “We are moving forward with our clinical development plans for…

FSD Pharma has completed dosing in the first group of healthy volunteers enrolled in its Phase 1 clinical trial testing Lucid-21-302, an oral medication candidate for all types of multiple sclerosis (MS). The medication, also known as Lucid-MS, was first given to a sentinel subject — one…

FSD Pharma will soon launch a first-in-human trial testing Lucid-21-302, known as Lucid-MS — its novel chemical treatment for multiple sclerosis (MS) — in healthy volunteers. Health Canada has cleared the company to initiate a Phase 1 clinical trial of the investigational therapy, FSD Pharma announced in a…

A treatment containing neural stem cells derived from a human fetus was shown to be well tolerated in a small clinical trial of people with progressive forms of multiple sclerosis (MS). Results showed some promising effects on markers of inflammation and brain atrophy. Researchers said these preliminary findings “warrant…

NVG-291, an experimental therapy designed to promote nervous system repair, has so far been well tolerated in an ongoing Phase 1 study with healthy volunteers. “The Phase 1 study is progressing very well, and we are encouraged by the data we are seeing so far,” Daniel Mikol, MD, PhD, chief…

Pipeline Therapeutics has initiated a Phase 1 clinical trial to investigate PIPE-307, its lead treatment candidate for multiple sclerosis (MS), in healthy volunteers. The trial (NCT04725175) will assess the compound’s safety, tolerability, and pharmacokinetics, or how the drug moves through the body. Up to 72 people, ages…

Researchers, working with an animal model of multiple sclerosis (MS), discovered that oral treatment with a synthesized plant peptide, known as cyclotide, halted the progression of clinical symptoms without side effects. The finding offers new hope for the development of an easily available and orally deliverable treatment that might slow or even…